Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/20/2018 |
Start Date: | May 2011 |
End Date: | May 2021 |
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This
evaluation is based on the number of lead-related complications occurring during the study
compared to the number of leads enrolled in the study. The leads will be followed for 5 years
after implant. This study is required by FDA as a condition of approval of the Model 4396 LV
Lead. This study is conducted within Medtronic's post-market surveillance platform.
evaluation is based on the number of lead-related complications occurring during the study
compared to the number of leads enrolled in the study. The leads will be followed for 5 years
after implant. This study is required by FDA as a condition of approval of the Model 4396 LV
Lead. This study is conducted within Medtronic's post-market surveillance platform.
Patients who meet all of the following inclusion criteria and do not meet any of the
following exclusion criteria are eligible for enrollment.
Inclusion Criteria
- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
- Patient has or is intended to receive an Attain Ability Model 4396 LV lead
- Patient within 30 day post implant enrollment window
Exclusion Criteria
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
We found this trial at
61
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Saint Vincent Mercy Medical Center Mercy St. Vincent Medical Center, established in 1855, is the...
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Winston-Salem, North Carolina
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